Comprehensive Evaluation of Ischemic Heart Disease Using MRI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Northwestern University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Astellas Pharma US, Inc.
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01234870
First received: October 5, 2010
Last updated: November 3, 2010
Last verified: November 2010
  Purpose

The aim is to develop a comprehensive cardiac Magnetic Resonance Imaging (MRI) protocol combining an Ultrafast perfusion technique, high resolution rapid cine and viability imaging together with whole heart coronary Magnetic Resonance Angiography (MRA). This new protocol will be tested in a group of volunteers and compared in patients using coronary angiography as the gold standard. It is expected that this improved comprehensive protocol for cardiac MRI be accurate at detecting significant coronary artery disease and may obviate the need for other more expensive and invasive diagnostic tests currently used.


Condition Intervention Phase
Heart Disease, Ischemic
Atherosclerosis, Coronary
Drug: adenosine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comprehensive Evaluation of Ischemic Heart Disease Using MRI

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Compare sensitivity and specificity in detection of significant coronary artery disease in patients that had been referred to the Catheterization Lab with suspected ischemic disease using the comprehensive cardiac Magnetic Resonance Imaging protocol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The results from the MR images analysis will be compared to conventional coronary angiography. Sensitivity, specificity, accuracy and statistical analysis will be carried out for each of the MR techniques separately and then combining results from all of the techniques together.


Secondary Outcome Measures:
  • Number of participants with adverse events to demonstrate feasibility of a comprehensive cardiac Magnetic Resonance Imaging protocol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Adverse events such as tolerability for drugs and scan time during a "one stop shop" coronary heart disease comprehensive cardiac MRI study.


Estimated Enrollment: 80
Study Start Date: August 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Adenosine
Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.
Drug: adenosine
Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins
Other Name: (Adenoscan)

Detailed Description:

Coronary heart disease is the leading cause of death and disability in the US, accounting for about one-third of all deaths in subjects over age 35.

With the development of newer Magnetic Resonance Imaging (MRI) techniques, such as faster pulse sequences and parallel imaging, cardiac MRI has become a routine tool for the evaluation and detection of myocardial ischemic disease. First pass myocardial perfusion (FPMP) using MRI is increasingly being used to assess ischemic heart disease. MRI offers the advantages of spatial resolution sufficient to differentiate between subendocardial and subepicardial perfusion; shorter examination time and also lack of ionizing radiation. Left ventricle cine gradient echo imaging can be used to assess regional ventricular function. Left ventricular myocardial viability can also be easily assessed at the same time in order to determine the amount of viable left ventricular myocardium and the percentage of irreversibly scarred myocardium by delayed enhanced images. Viability imaging is usually added to the perfusion protocol to increase specificity by allowing detection of fixed perfusion defects, which represent scar. The ultimate cardiac MRI protocol would be to combine both of these imaging strategies with a reliable and accurate coronary Magnetic Resonance Angiography(MRA) technique, such that obstructive coronary artery disease could be evaluated comprehensively at the same time. If all of these techniques can be combined together in a single study, it may be feasible to finally achieve a "one stop shop" for cardiac MRI.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Under an Institutional Committee on Human Research board approved protocol, 20 normal volunteers, without a known history of coronary artery disease or a history of myocardial infarction or injury and 80 patients with a suspected myocardial ischemic disease recruited from the cardiac cath laboratory will be included in this prospective study. All subjects will be screened for (Glomerular filtration rate) GFR within 24 hours before the exam. All healthy volunteers must have a GFR > 60 mL/min/1.73m2 to be enrolled. All patients must have a GFR > 30 mL/min/1.73m2 to be part of the study.

All subjects will be selected following the Nephrogenic Systemic Fibrosis (NSF) guidelines. All dialysis patients or end-stage renal disease patients with a creatinine clearance of < 30 mL/min will not be selected for the study to avoid NSF. Patients with GFR < 60 ml/min but >30 ml/min will receive a reduced dose of Gadolinium contrast (0.1 ml/kg).

Exclusion Criteria:

  1. Age <18 years;
  2. Known contraindication to MR imaging (such as pacemaker placement, magnetic implants, etc);
  3. Claustrophobia;
  4. Inability to perform an adequate breath-hold for imaging,
  5. Inability to provide informed consent;
  6. all subjects will be will be screened for GFR within 24 hours before the exam and subjects presenting with GFR < 30 ml/min will be excluded;
  7. Pregnant and lactating women;
  8. All healthy volunteers with hypersensitivity to gadolinium contrast agents;
  9. Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine, or nitroglycerin;
  10. Contra indication for Adenosine

    1. 2nd- or 3rd-degree atrioventricular block (except in patients with a functioning artificial pacemaker)
    2. Sinus node disease (except in patients with a functioning artificial

      pacemaker)

    3. Unstable angina
    4. Acute myocardial infarction
    5. Known or suspected bronchoconstrictive or bronchospastic lung

      disease (e.g., asthma)

    6. Hypersensitivity to adenosine
    7. Caffeine within 12-24 hours
    8. Theophylline and Dipyridamole products within 24 hours.
  11. Contra indication for Metoprolol

    1. sinus bradycardia
    2. heart block greater than first degree
    3. Cardiac Failure
    4. Bronchospastic Disease
  12. Contra indication for Nitroglycerin

    1. Early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin.

b .Administration of Nitrostat (nitroglycerin tablets, USP) is contraindicated in patients who are using Viagra® since Viagra has been shown to potentiate the hypotensive effects of organic nitrates.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234870

Contacts
Contact: James C Carr, MD 312-695-4218 jcarr@northwestern.edu
Contact: Aya Kino, MD 312-695-0890 a-kino@northwestern.edu

Locations
United States, Illinois
Northwestern University Enrolling by invitation
Chicago, Illinois, United States, 60611
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: James C Carr, MD    312-695-4218      
Contact: Aya Kino, MD    312-695-0890      
Principal Investigator: James C Carr, MD         
Sponsors and Collaborators
Northwestern University
Astellas Pharma US, Inc.
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators
Principal Investigator: James C Carr, MD Northwestern University
  More Information

No publications provided

Responsible Party: James C. Carr/ MD, Northwestern University
ClinicalTrials.gov Identifier: NCT01234870     History of Changes
Other Study ID Numbers: CR1_STU00006013, ASCA-9J02
Study First Received: October 5, 2010
Last Updated: November 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Myocardial Perfusion Imaging
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Pathologic Processes
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 31, 2014